Information

A GUIDE FOR fourth edition

Editors

Patrick M. Malone, FASHP Karen L. Kier, PhD, MSc, RPh Associate Dean of Internal Affairs and Professor of Clinical Pharmacy

Professor of Pharmacy Practice Director of College of Pharmacy Raabe College of Pharmacy The University of Findlay Ohio Northern University

Findlay, Ohio Ada, Ohio

John E. Stanovich, RPh Assistant Professor of Pharmacy Practice Assistant Dean for External Pharmacy The University of Findlay Findlay, Ohio

Gravi/ Hill

York • Chicago • San Francisco • Lisbon • London • Madrid • Mexico City • Milan

New Delhi • Juan • Seoul • Singapore • Sydney • Toronto

Contents

Contributors xviii

Preface xxiii

Chapter One. Introduction to the Concept of

Medication Information 1 Mary Lea Gora-Harper Russell May

Introduction 2

The Beginning 4

The Evolution 6

Opportunities in Specialty Practice 19

Summary and Directions for the Future 25

Questions 26

Chapter Effective Responses and Recommendations:

A Approach 35 Anton and Heck Sheehan

Accepting Responsibility and Barriers 36

Identifying the Genuine Need 37

Formulating the Response 41

Case Study 2-1 45

2-2 46

2-3 50

Case Study 2-4 53

Conclusion 56

Self-Assessment Questions 57

Vi CONTENTS

Chapter Three. Drug Information Resources 59 Kelly M. Shields and Elaine Blythe

Introduction 60

Tertiary Resources 61

General Product Information 66

Adverse Effects 69

3-1 70

Availability of Dosage 70

70

Dietary Supplements 72

Dosage (Organ 73

Drug Interactions 73

Dosage Recommendations 75

Identification of Product 75

and Stability 75

International Drug Equivalency 76

Pediatric Dosage Recommendations 77

78

78

Pharmacy Law 79

Teratogenicity/Lactation 80

Case Study 3-2 81

Therapy of Choice 81

Toxicology 82

Case Study 3-3 83

Veterinary Medicine 83

3-4 85

Case Study 3-5 87

Selecting a Format for Tertiary Resources 89

References for PDA/Mobile Devices 89

Secondary Literature 90

3-6 96

Literature 96

CONTENTS

Alternative Resources 98

Alternative Information Sources 99

Case Study 3-7 100

Health Information 101

Conclusion 102

Case Study 3-8 103

Self-Assessment Questions 103

Chapter Four. Literature Evaluation I: Controlled Clinical Evaluation 111

Michael Kendrach, Maisha Kelly Terri M. Wensel, and J. Hughes

Literature 114

Approach to Evaluating Research Studies (True Experiments) 116

Journal, Peer-Review, and Investigators 117

Title 119

Abstract 120

Introduction 120

Methods 122

Results 147

Discussion/Conclusion 154

Clinical Trial Result Interpretation 156

Bibliography 167

167

Funding 168

Trial Critiques 170

Conclusion 172

4-1 173

4-2 174

4-3 175

Self-Assessment Questions 176

Chapter Five. Literature Evaluation II: Beyond the Basics 193 J. Bryant, Karen P. Norris, McQueen, and Elizabeth A.

Introduction 195

Beyond the Basic Controlled Trial 196

VII j CONTENTS

Case Study 5-1 201

Observational Study Design 214

Case Study 5-2 221

Reports Without Control Group 227

Survey Research 228

Postmarketing Surveillance Studies 233

Review Articles 234

Case Study 5-3 243

Practice Guidelines 244

Health Research 245

Dietary Supplement Medical Literature 250

Case Study 5-4 254

Conclusion 255

Acknowledgments 257

Self-Assessment Questions 258

Chapter Six. Pharmacoeconomics 269 James P. Wilson and Karen L. Rascati

Introduction 270

Pharmacoeconomics: What and Do 271

Relationship of Pharmacoeconomics to Outcomes Research 271

of 271

of Costs 272

Assessment of Outcomes 274

Performing an Economic Analysis 283

What Is Decision Analysis? 288

Steps in Reviewing Published Literature 292

Case Study 6-1 293

Selected Pharmacoeconomics Web Sites 295

Conclusion 295

Study Questions 296

Self-Assessment Questions 296

CONTENTS IX

Chapter Seven. Evidence-Based Clinical Practice Guidelines . . . . 303 Kevin G. Moores

Introduction 305

Evidence-Based Practice and Clinical Practice Guidelines 307

Guideline Development Methods 311

Case Study 7-1 321

Study 7-2 326

Interpretation of Guideline Recommendations 332

Case Study 7-3 337

Guideline Evaluation Tools 337

Implementation of Clinical Practice Guidelines 340

Case Study 7-4 345

Sources of Clinical Practice Guidelines 345

Conclusion 350

350

Self-Assessment Questions 350

Chapter Eight. The Application of Statistical Analysis

in the Biomedical Sciences 361 Ryan W. Walters and Karen L. Kier

Basic Concepts 362

Statistics 377

Case Study 8-1 381

Statistical Inference 382

The Design and Analysis of Clinical Trials 391

Statistical Techniques 398

8-2 428

Case Study 8-3 452

Conclusion 453

Self-Assessment Questions 454

Chapter Nine. Professional Writing 461 Patrick M.

Introduction 462

Steps in Writing 463

X CONTENTS

Referees 478

9-1 479

Specific 479

9-2 486

Case Study 9-3 493

Conclusion 495

Self-Assessment Questions 495

Chapter Ten. Legal Aspects of Drug Information Practice 505 Martha M. Rumore

Introduction 506

Law 507

Case Study 10-1 509

Case Study 10-2 510

Defenses to Negligence and Malpractice Protection 519

Labeling and Advertising 524

Liability Concerns for Web 2.0 Information 531

Intellectual Property Rights 537

Case Study 10-3 540

Privacy 545

Case Study 10-4 547

Industry Support for Educational Activities 549

Conclusion 553

Chapter Eleven. Ethical Aspects of Drug

Information Practice 563 Linda K. Ohri

What Is Ethics and What Is Not 564

Ethical Dilemmas When Providing Drug Information 566

Basics of Ethics Analysis 568

Case Study 11-1 576

Case Study 11-2 586

Case Study 11-3 587

Self-Assessment Questions 588

CONTENTS XI

Chapter Twelve. Pharmacy and Therapeutics Committee 595 Patrick M. Mahne, L. Fagan, MarkA. Malesker, J. Nelson

Introduction 596

Organizational Background 598

Case Study 12-1 612

Case Study 12-2 626

Clinical Guidelines 630

Standard Order Set Development 630

Credentialing and Privileges 631

Quality Within the P&T Audit 632

Case Study 12-3 637

Within an Organization 637

Conclusion 639

Acknowledgment 640

Study Questions 640

Self-Assessment Questions 640

Chapter Thirteen. Drug Evaluation Monographs 655 Patrick M. Mahne, Nancy L. Fagan, Mark A. Malesker, Paul], Nelson, and Linda K. Ohri

Introduction 656

Conclusion 678

Case Study 13-1 678

Case Study 13-2 678

Acknowledgment 679

Self-Assessment Questions 679

Chapter Quality Improvement and the Medication Process 687

Mark A. Ninno and Sharon Davis Ninno

Quality Improvement 689

Drug Regimen Review and Drug Use Review 702

Case Study 14-1 703

Case Study 14-2 713

XII CONTENTS

Case Study 14-3

Quality in Drug Information

Conclusion

Self-Assessment Questions

Chapter Fifteen. Medication Misadventures I:

Adverse Drug Reactions 733 J. Gregory Risoldi Cochrane

Introduction to Adverse Drug Reactions 734

Case Study 15-1

Conclusion

Study Questions

Self-Assessment Questions 750

Chapter Sixteen. Medication Misadventures II: Medication

and Patient Safety 757 Crea

Introduction

Medication Errors, Adverse Drug Events (ADEs), and Adverse Drug Reactions (ADRs) 759

The Impact of Errors on Patients and Health Care Systems 763

Identification and Reporting of Medication Errors and Adverse Drug Events

Case Study 16-1

Human Error or System Error? 777

Case Study 16-2

A Just and 782

Case Study 16-3

Risk Factors for Errors and Events

Health Professions Education

Best Practices for Error Prevention

Conclusion: Safety as a Priority 799

Self-Assessment Questions

CONTENTS XIII

Chapter Seventeen. Investigational Drugs 807

Introduction 809

810

History of Drug Development Regulation in the United States 812

Case Study 17-1 815

The Drug Approval Process 816

Case Study 17-2 825

The Orphan Drug Act 825

Case Study 17-3 826

The Institutional Review Board 826

Case Study 17-4 828

of the Health Care Professional 829

Conclusion 835

Self-Assessment Questions 836

Chapter Eighteen. Policy Development, Project Design, and Implementation 845

Krick Evans

Introduction 846

Policy Development 846

Case Study 18-1 855

Project Basics 857

Project Definition 858

Project Development 862

Project Implementation 866

Project Closeout 866

Project Management 867

Conclusion 868

Self-Assessment Questions 869

Chapter Nineteen. Drug Information in Care 871 Debra L. Parker

Introduction 872

Why Focus on Drug Information in the

XIV CONTENTS

Applying Drug Information in an Care Setting 873

Drug Information in the Ambulatory Setting 875

Drug Information Responsibilities in Ambulatory Care 877

Patient Disposal of Unused Medications 884

Providing Information 885

Quality Assurance Considerations in Ambulatory Care 887

Conclusion 889

Self-Assessment Questions 889

Chapter Drug Information and Contemporary Community Pharmacy Practice 895

Morgan L. Sperry and Patricia A. Marken

Introduction 896

as Drug Information Providers in the Community Setting 898

Current Patient Sources of Drug Information 899

A New Model of Drug Information in the Community 904

Conclusion 909

Case Study 20-1 909

Self-Assessment Questions 910

Chapter Twenty-One. Drug Information Education and Training 917

Kelly M.Smith

Introduction 918

Foundational Development 918

Specialized Skill Development 922

Pursuing Specialty Training 924

Conclusion 924

Self-Assessment Questions 925

Chapter Twenty-Two. Pharmaceutical Industry and Regulatory Affairs 931

Jean E. Davison

Introduction 932

Opportunities for Within Industry 933

CONTENTS XV

Regulation of HCPs in Industry 937

Case Study 22-1 938

PhRMA and the Code on Interactions With Health Care Professionals 939

Case Study 22-1 Continued 939

of Medical Information Requests 939

Case Study 22-1 Continued 941

Adverse Event Reporting 942

Case Study 22-1 Continued 944

Staying Connected With the Industry 946

of Regulatory Agencies 946

Division of Drug Information at the FDA 948

Drug Information Services Provided by the FDA 950

22-2 952

Drug Information Resources 953

Opportunities Within the FDA 955

Conclusion 957

Self-Assessment Questions 957

Appendix 2-1. Drug Consultation Request Form 967

Appendix 2-2. Sample Questions for Obtaining Background Information

Requestors 969

Appendix 3-1. a PubMed Search 974

Appendix 3-2. Selected Literatures Sources 978

Appendix 4-1. Questions for Assessing Clinical Trials 980

Appendix 5-1. Beyond the Basics: Questions to Consider for

Critique of Primary Literature 983

Appendix 7-1. New Zealand Guidelines Group (NZGG) 989

Appendix 7-2. National Institute for Clinical Excellence 990

Appendix 7-3. National Institute for Clinical Excellence (NICE) Topic Selection Criteria 991

Appendix 7-4. Study Selection for Reviews and (CRD) 994

Appendix 7-5. Study Selection for Reviews and Dissemination (CRD) 995

XVI CONTENTS

Appendix 7-6. Data for Reviews and

Dissemination (CRD) 996

Appendix 7-7. National Institute for Clinical Excellence (NICE)—

Evidence Table Format for Intervention Studies 998

Appendix 7-8. New Zealand Guidelines Group (NZGG)—

Considered 1000

Appendix 7-9. Guidelines Advisory Committee (GAC) Levels of

Evidence Grades of Recommendation 1001

Appendix 7-10. National Institute for Clinical Excellence (NICE)

Guideline Structure 1004

Appendix 7-11. Scottish Intercollegiate Guidelines Network (SIGN)

Consultation and Peer-Review 1006

Appendix 7-12. Grades of Recommendation Assessment Development

and Evaluation (GRADE) System Advantages 1007

Appendix 7-13. Appraisal of Guidelines Research and

Evaluation (AGREE) Instrument 1009

Appendix 7-14. Conference on Guideline

Standardization (COGS) Checklist 1010

Appendix 7-15. Implementation Strategies 1012

Appendix 9-1. Question 1014

Appendix 9-2. Abstracts 1016

Appendix 9-3. Bibliography 1020

Appendix 11-1. Code of Ethics for 1034

Appendix 12-1. Pharmacy and Therapeutics Committee Procedure 1036

Appendix 12-2. Request Form 1050

Appendix 12-3. P&T Committee Meeting Attributes 1052

Appendix 12-4. Example P&T Committee Minutes 1054

Appendix 12-5. Chairperson Skills 1056

Appendix 12-6. Declaration 1058

Appendix 13-1. Format for Drug Monograph 1060

Appendix 13-2. Example Drug Monograph 1063

Appendix 14-1. of Quality Assurance and Total Quality Management in Health Care 1069

Appendix 14-2. Tools Used in Quality Improvement 1071

CONTENTS XVII

Appendix 14-3. of Approaches to Quality Improvement 1076

Appendix 14-4. Example of a Quality Improvement Activity Plan 1078

Appendix 14-5. Example Results 1081

Appendix 14-6. Example MUE Results 1083

Appendix 14-7. Quality Evaluation: Response to

Drug Information Request 1086

Appendix 15-1. Questionnaire 1087

Appendix 15-2. Naranjo 1094

Appendix 15-3. Jones Algorithm 1095

Appendix 15-4. MedWatch Form 1096

Appendix 17-1. Investigational New Drug Application 1099

Appendix 17-2. Statement of Investigator 1101

Appendix 17-3. Protocol Medication Economic Analysis 1103

Appendix 17-4. Investigational Drug Accountability Record 1104

Appendix 18-1. High-Alert Medications 1105

Appendix 18-2. Medication Shortages and Backorders 1110

Appendix 19-1. FDA Guidelines for Proper Medication Disposal 1115

Appendix 22-1. Response Letter Drug of Yellow Stripes

Glossary 1119

Answers for Case Studies 1137

Answers for Self-Assessment Questions 1151

Index 1157